Medical Devices

Infusion Pumps

An infusion pump is a medical device that delivers fluids, such as nutrients and medications, into a patient’s body in controlled amounts. Infusion pumps are in widespread use in clinical settings such as hospitals, nursing homes, and in the home.

In general, an infusion pump is operated by a trained user, who programs the rate and duration of fluid delivery through a built-in software interface. Infusion pumps offer significant advantages over manual administration of fluids, including the ability to deliver fluids in very small volumes, and the ability to deliver fluids at precisely programmed rates or automated intervals. They can deliver nutrients or medications, such as insulin or other hormones, antibiotics, chemotherapy drugs, and pain relievers.

There are many types of infusion pumps, including large volume, patient-controlled analgesia (PCA), elastomeric, syringe, enteral, and insulin pumps,. Some are designed mainly for stationary use at a patient’s bedside. Others, called ambulatory infusion pumps, are designed to be portable or wearable.

Because infusion pumps are frequently used to administer critical fluids, including high-risk medications, pump failures can have significant implications for patient safety. Many infusion pumps are equipped with safety features, such as alarms or other operator alerts that are intended to activate in the event of a problem. For example, some pumps are designed to alert users when air or another blockage is detected in the tubing that delivers fluid to the patient. Some newer infusion pumps, often called smart pumps, are designed to alert the user when there is a risk of an adverse drug interaction, or when the user sets the pump’s parameters outside of specified safety limits.

Over the past several years, significant safety issues related to infusion pumps have come to FDA’s attention. These issues can compromise the safe use of external infusion pumps and lead to over- or under-infusion, missed treatments, or delayed therapy.

From 2005 through 2009, FDA received approximately 56,000 reports of adverse events associated with the use of infusion pumps, including numerous injuries and deaths. During this time period, manufacturers conducted 87 infusion pump recalls to address identified safety concerns. Seventy of these recalls were designated as Class II, a category that applies when the use of the recalled device may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. Fourteen recalls were Class I – situations in which there is a reasonable probability that use of the recalled device will cause serious adverse health consequences or death. These adverse event reports and device recalls have not been isolated to a specific manufacturer, type of infusion pump, or use environment; rather, they have occurred across the board.

Although some adverse events may be the result of user error, many of the reported events are related to deficiencies in device design and engineering, which can either create problems themselves or contribute to user error. The most common types of reported problems have been associated with software defects, user interface issues, and mechanical or electrical failures and are explained on the Examples of Reported Infusion Pump Problems page.

In 2010 the FDA announced three steps it would take to improve infusion pump safety. These steps were to (1) increase user awareness, (2) proactively facilitate device improvements, and (3) publish new guidance for industry. For more information on FDA’s progress in completing these steps see the Infusion Pump Improvement Initiative page.

On this website, you can learn more about infusion pump problems, actions FDA is taking to improve pump safety, strategies to reduce pump-related risks, and how to report problems to FDA.